Clinical Trial

A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2023-04-28; most recent amendment 2026-07-20.
Status change: Recruiting → Active, Not Recruiting 2026-07-20
Status change: Not Yet Recruiting → Recruiting 2023-06-20
Trial Details
NCT Number NCT05848739
Lead Sponsor Sapience Therapeutics
Conditions Colon Cancer, Metastatic Colon Cancer
Enrollment 130 participants
Start Date 2023-06-05
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-22